Annual Report - SAPC

South African Pharmacy Council
Annual Report 2018
It is our pleasure to submit the Annual Report on the activities of the South African Pharmacy Council for the period of 1 January
2018 – 31 December 2018, in terms of the Pharmacy Act, 53 of 1974.
ISBN: 978-0-6398363-0-0
PRESIDENT REGISTRAR
South African Pharmacy Council 2013 - 2018 Seated: Chairperson CPI: Mr Tshuba Solomon Rasekele; Chairperson Education: Prof Roderick Bryan Walker; Chairperson CII: Mr Rajatheran (Sham)
Moodley; Chairperson Health: Mr Vusi Cornelias Dlamini; Chairperson Practice: Ms Jacqueline Ann Maimin; President: Prof Manoranjenni (Mano) Chetty; Vice-President: Mr Douglas James Heaslet Defty; NDoH Representative: Mr Gavin Stewart Steel; Treasurer: Ms Nocawe Portia Thipa;
Chairperson CPD: Dr Panjaseram (Vassie) Naidoo; Registrar/CEO: Mr Tokolo Amos Masango Standing: Mr Johannes Stephanus du Toit; Ms Josephine Winley Herbert; Prof Shirley-Anne Inez Boschmans; Ms Rachel Verity Wrigglesworth;
Mr Charles John Cawood; Ms Helen Catherine Hayes; Mr Mathys Jacobus Snyman; Mr Johannes Albertus Raats; Dr (Adv) Nazreen Shaik-Peremanov; Ms Claudette Norina Jasson; Mr Hezron Tshepo Mphaka; Mr Panajiotaki George Kyriacos
Absent: Mr Ayanda Soka; Ms Letty Mahlangu; Mr Gaoboihe Jonas Kgasane
2 2018 South African Pharmacy Council Annual Report
2018 ANNUAL REPORT 1 VISION 6 MISSION STATEMENT 6 CORE VALUES 6 PRESIDENT’S MESSAGE 7 FOREWORD: REGISTRAR & CEO 9 COUNCIL – ROLE AND RESPONSIBILITIES 11
Objectives and Functions of Council 11 Governance Structure 11 Council Members (2013 – 2018) 11 Council Members (2018 – 2023) 12
CORPORATE SERVICES 13 Strategic focus area 13 Council meetings 13 Board notices 13 Strategic plan 2014 – 2018 13 Operational plans 2018 and 2019 13 National/International Conferences 13 2018 Attendance at meetings 13
COMMUNICATION AND STAKEHOLDER RELATIONS (CSR) 16 Strategic focus area 16 Corporate Communication 16
3rd National Pharmacy Conference 16 SAPC IP PBX self-help functionality 16 SAPC website 16
Public and media relations 16 Reactive media interactions 16 Pro-active media interactions 16 Social & Digital media 17 2018 Pharmacy Month 17 Publications 17
Internal communication 18 Language Support 18 SAPC renovated Wozanibone Secondary High School on 17 August 2018 in honour of Nelson Mandela’s Centenary 18 Stakeholder Relations 18
Online application and payment functionality 19 Service Delivery surveys 19
Service Delivery Ratings 19 Contact Centre 19
Telephones 19
32018 South African Pharmacy Council Annual Report
Front desk and pre-audit of manual applications 20 Logistics Centre 20 ID registration cards 20
PROFESSIONAL AFFAIRS – PRACTICE 21 Strategic focus area 21 Practice Committee 21 Standard setting 21
Minimum standard for the sale of HIV self-screening test kits 21 Professional standard for services offered from a pharmacy 21 Minimum standard for unit dose dispensing 21 Minimum standard for locum tenens pharmacists and pharmacy support personnel 22 Minimum standard for pharmacy administration and management 22 Minimum standards for alternative models of delivery of medicines 22 Another business or practice in a pharmacy 22 Minimum standard relating to the supervision of pharmacy support personnel 23 Survey for reference sources that must be accessible in each category of pharmacy 23
Pharmacy Inspectors (Council Officers) 23 Pharmacy Inspection tool (Inspection questionnaires) and grading of pharmacies 23 Inspections of pharmacies 24 Good Pharmacy Practice recommendations: Licensing and recording of pharmacies 25 Good Pharmacy Practice recommendations: Section 22A(15) permit recommendations 25
Recommendations in terms of Section 56(6)(d) of the Nursing Act, 33 of 2005 26 Other matters discussed by the Practice Committee 26 Premises approval for the training of pharmacist interns and pharmacy support personnel 27 Meetings facilitated by the Practice Unit 27
PROFESSIONAL AFFAIRS – CPD AND REGISTRATIONS 28 Strategic focus area 28 Committees 28
Continuing professional development (CPD) Committee 28 Health Committee 28
Registrations 28 Review of competency standards for pharmacists in South Africa 28 Pharmacy Internship 28 Competency portfolio for pharmacist interns 29 Pre-registration examinations for interns 29 Candidates with qualifications obtained outside South Africa 29
Applications for recognition of foreign qualifications 29 Professional examination 29
PROFESSIONAL AFFAIRS – EDUCATION 30 Strategic focus area 30 Education Committee 30 Good education standards 30 Qualifications 30 Criteria and Guidelines 30 Cooperation with other quality councils 30
Accreditation/monitoring visits to Higher Education and Training providers 31 Accreditation of courses 31 Heads of schools meeting 31 Meeting of the skills development providers 31
INFORMATION TECHNOLOGY 32 Strategic focus area 32 Operational matters 32
Business Continuity and Disaster Recovery Planning 32 Migrating the Microsoft mailboxes from on-premises to Microsoft Office 365 32 Computing tools 32 The Register & Dashboard 32
HUMAN RESOURCES 33 Strategic focus area 33
LEGAL SERVICES & PROFESSIONAL CONDUCT 35 Strategic focus area 35 Introduction 35 Professional conduct 35
Committee of Preliminary Investigation 35 Committee of Informal Inquiries 35 Committee of Formal Inquiries 36
Provision of legal services and legal administration 36 Legal Enquiries and Legal Opinions 36 Certificates of Good Standing 36 Section 26 Certificates 36 Contracts and Service Level Agreements 36
Corporate governance 36 Legislation 36
South African Pharmacy Council Legislation 36 Comments and contributions to proposed legislation published for comment 37
Council Elections 2018 37 FINANCIAL MANAGEMENT 38
Strategic focus area 38 Coordination of standing committees of Council 38
Audit Committee 38 Pension Fund Board 38
Promotion of transparency to the profession and the general public 38 Councillors 38 Code of conduct 38 Audit Committee 38 Financial statements 39
Provision of managerial and administrative support for the sustainability of Council as a going concern 39 Financial performance indicators 39 Financial position 39 Comprehensive income 39 Budgetary control 40
Supply chain management 40 Risk management 40 Internal audit 40
REPORT OF THE AUDIT COMMITTEE 42 Purpose of the annual report 42 Audit Committee members and attendance 42 Audit Committee responsibility 42 Internal and external auditors 42 Effectiveness of internal control 42 Evaluation of financial statements 42 Going concern basis of accounting 42 Risk management 42 Irregularities and supply chain management 42
FINANCIAL STATEMENTS 43 SOUTH AFRICAN PHARMACY COUNCIL FINANCIAL STATEMENTS FOR THE YEAR ENDED 31 DECEMBER 2018 43
GLOSSARY OF TERMINOLOGY 67
Vision, Mission, Core Values
We exist to:
• protect the public by improving health outcomes
• assist in promoting access to sustainable quality pharmacy services by embracing the use of innovation and technology
• ensure quality pharmaceutical services by developing, enhancing and upholding universally acceptable education and
practice standards through stakeholder engagement
• promote the dignity of the profession through professional ethics and conduct, and ongoing competence
• People first – we care, we serve, we collaborate, we belong to the community
• Integrity – we will be ethical, transparent and honest in conducting our business
• Accountability – we are responsible and answerable for our actions
• Professionalism – we will develop our staff to perform their work with expertise, dedication, care and act in a competent
and excellent manner at all times
Dear Colleagues,
October 2018 marks the end of the term of office of the current Council members who served from 2014 to 2018. I would like to take this opportunity to reflect on some of the activities of the South African Pharmacy Council during this period that were directed at achieving some of the key objectives set in 2014, to advance and uplift the pharmacy profession.
Development of plans to address the shortage of pharmacists and pharmacy support personnel This objective was adopted to address the shortage of pharmacy human resources in the country as highlighted in the World Health Organisation (WHO) study conducted in 2009. The study was based on WHO norms regarding the number of pharmacists and support personnel relative to the population numbers requiring a pharmaceutical service. In the past five years, pharmacists numbers have increased by about 12% and support personnel have increased by 17%. However, it has become evident that the findings of the 2009 study may have to be re-evaluated within the South African context. There appears to be a limited capacity of the South African healthcare system to accommodate newly qualified pharmacists in community service and to employ pharmacists and pharmacy support personnel. This has caused serious concern for Council, who work with the national Department of Health (DoH) annually to assist with managing the problem.
Support for education and training of a greater number of pharmacists and pharmacy support personnel The reduction in fees associated with education and training by the present Council was the first contribution to this focus area. Institutes of education and training have endeavoured to enrol a greater number of students to their programs. Various systems and processes were implemented within the SAPC to enhance and streamline pre-registration examinations and other related processes. Unfortunately, another hurdle was recently encountered where pharmacy students experienced difficulties with finding internship positions. There appears to be limited capacity in the country for placement of pharmacy interns since the public health sector can employ only a limited number of pharmacy interns. The SAPC appeals to pharmacists in other sectors of pharmacy to offer internship positions to assist with the education and training of our future pharmacists.
Consideration of innovative methods of delivery of pharmaceutical services, especially in underserviced areas During the past four years, the national and provincial health departments, with the objective of improving access to medicines and reducing patient waiting times in health care facilities, have proposed various new models for drug
delivery. Council has developed good practice guidelines to support good patient care as well as the integrity of the medicines being delivered when using these models. Delivery models that may compromise the patient or the medicines have not been supported by Council.
Colleagues, I would like to emphasise that these alternative delivery models were introduced to satisfy a critical need in our country. Support and active participation by our profession in promoting better access to medicines is essential to ensure our rightful role in the healthcare system.
Evaluation of the roles of pharmacists and pharmacy support personnel in the proposed new national healthcare system (National Health Insurance – NHI) In preparation for changes in the health care system, the core competencies and curricula of all pharmacy personnel have been reviewed. The supportive regulations are awaiting processing by the DoH.
Support and encouragement for the profession to engage in healthcare issues of national and global concern The 2nd National Pharmacy Conference hosted in Durban in 2016 provided a good platform for pharmacists to exchange ideas and experiences with colleagues from across South Africa and abroad. This was a very successful conference that was attended by about 1200 delegates. Some planning for the 3rd National Pharmacy Conference, to be held at Sun City in 2019 has commenced and will be continued by the next Council.
Council also participated in awareness campaigns relating to antibiotic resistance, the Ebola epidemic in specific African countries and the national call for the promotion of vaccinations.
President’s Foreword
Enhancement of the services and communication between the profession, the public and the Office of the Registrar and his team This is an area that received special attention from Council. A work-study was commissioned to investigate how professional services and customer care can be improved within the Office of the Registrar. Various new processes have been implemented for online registrations and the funding has been approved for the installation of new digital systems to record and track customer queries. It is hoped that in the next year a superior customer care service will be delivered.
A more collaborative approach has been encouraged when pharmacies are reviewed for compliance with Good Pharmacy Practice (previously called inspections). Compliance officers/ monitors (previously called inspectors) have been trained to work together with pharmacists to identify and rectify areas that may require improvement.
Promotion of closer collaboration between SAPC and other health statutory bodies The Minister of Health has established a forum at which all health statutory bodies meet. The Deputy Director-General: National Health Insurance, Dr Anban Pillay, has conducted several successful meetings that have encouraged discussions between the different statutory bodies. I feel privileged to report that the SAPC is ahead of the pack in many respects, including regular unqualified audits. Well done to the Registrar and his team!
These are just a few of the achievements of Council during the 2014-2018 period. Although Councillors and staff in the Office of the Registrar are not always popular with members of the profession, I have witnessed the total dedication from Councillors, as well as staff, to uplift and support the pharmacy profession. Thank you Councillors, the Registrar and the office staff.
The names of all the new Council members have not been announced at this stage. However, I would like to wish the new Council a successful 5-year term.
I would like to thank all pharmacists and pharmacy support personnel for the opportunity to serve you for the past five years.
On behalf of Council, I wish you and your families an enjoyable festive season.
Prof. Mano Chetty President
Despite having too many irons in the fire, the South African Pharmacy Council counts 2018 among our best years in terms of executing our legislative mandate while delivering on our operational commitments. To attest to the efficiency of the good governance structures, financial management systems and a culture of ethical business conduct instilled in the SAPC, we have attained our 10th unqualified audit opinion.
This year we have had to focus our energies chiefly on the 2018 Council Elections and ensuring that final preparations for the 3rd National Pharmacy Conference were carried out. While this was happening, the work of fulfilling the objects of Council as espoused in the Pharmacy Act (Act 73 of 1974) needed to continue unabated. The 2018 South African Pharmacy Council Annual Report succinctly highlights our progress in terms of attaining the legislated purpose of our existence.
2018 Council Elections Following the issuing of the notice of elections by the Returning Officer in April 2018, pharmacists across the country nominated 72 candidates to run for elections. The list of the nominees was duly published in the government gazette in June 2018. The elections process, steered by the Independent Electoral Commission of South Africa (IEC), was concluded in October 2018. However, following the conclusion of the vote-counting several stakeholders petitioned the results. This necessitated a rigorous independent investigation, the results of which indicated that the elections were free, fair and transparent. This then paved way for the announcement of the new 25-member Council on 21 December 2018.
3rd National Pharmacy Conference The third National Pharmacy Conference will take place at Sun City, in North West in October 2019. This national dialogue and continuing professional development opportunity is planned for 1200 delegates, making it one of the biggest pharmacy conferences on the continent. Skills transfer and the sharing of best practice would occur in more than 30 workshops, while discussions on issues affecting the pharmacy professional and health care in general will be discussed at lengths in several commissions.
Work on the conference booking system, securing the conference venue, programme, communication channels and the appointment of the conference secretariat has been concluded.
Fulfilling the objects of Council Objects 3(c), (d), (g), (e)(iv), and (e)(v), as contained in the Pharmacy Act, bestow on the SAPC the responsibility to set, maintain and uphold standards that ensure good pharmacy practice with the specific aim of delivering definite therapeutic outcomes for patients and safeguarding the rights of the public to universally acceptable pharmaceutical care, thus maintaining and enhancing the dignity of the profession and the integrity of those practising the calling. Setting universally acceptable standards Over the period under review, we have developed, reviewed and published, among others, the following documents in pursuit of ensuring that the profession operates under the
guidance of up-to-date, universally acceptable and fit-for- purpose minimum standards: • Competency Standards for Pharmacists in South Africa • Amendments to the Rules relating to Good Pharmacy
Practice • Regulations relating to Continuing Professional
Development (for comment) • Minimum standards for unit-dose dispensing (for
comment) • Professional standards for services offered from a
pharmacy • Minimum standards for locum tenens pharmacists and
pharmacy support personnel • Minimum standards for pharmacy administration and
management • Minimum standards for alternative models for the
delivery of medicines • Minimum standards relating to the supervision of
pharmacy support personnel
Protecting the dignity and integrity of the profession, safeguarding the rights of patients During the current reporting period, we conducted 1 815 inspections across the country – a majority of which (80%) were monitoring inspections. A basic analysis of the inspection results indicates that the provinces with the highest Good Pharmacy Practice (GPP) compliance rates for pharmacy premises inspected in 2018 are the Western Cape and Free State, with 95% and 93% of premises achieving either A or B grading respectively. The results further show that Limpopo (49%), Gauteng (25%), North West (25%), Eastern Cape (24%), Northern Cape (24%), and KwaZulu- Natal (22%) had concerning proportions of pharmacy facilities graded either C or D. Our monitoring officers do their best to identify shortcomings and suggest ways to improve compliance, we hope that responsible pharmacists within the under-complying facilities will improve on the identified shortcomings in the coming year.
In our quest to improve compliance rates, we have appointed six additional officers to the SAPC Inspectorate and work has begun on the review of the inspection-scoring matrix, the
Foreword: Registrar & CEO
Amos Masango (Registrar/CEO)
inspection questionnaire and to develop an inspections computer application.
The disciplinary committees of Council attended to a total of 454 cases during the current reporting period, representing an increase in cases of 111 when compared with 2017 (343 cases).
Advancing human resources for pharmacy Both the Pharmacy Act and the Human Resources Plan for Pharmacy bestows the responsibility of driving efforts to ensure that the country has access to adequately trained pharmacy professionals on the SAPC. In the spirit of the Act and objectives pronounced in the Human Resources Plan for Pharmacy, the Office of the Registrar together with the relevant committees of Council ensured that 10 702 new persons were registered under various categories on the SAPC Register. A majority of the new registrations were comprised of leaners and BPharm students (4 675), followed by pharmacist’s assistants (3 691), post-community service pharmacists (760), pharmacist interns (740) and community service pharmacists (674). Persons registered in the pharmacy technician (80) and pharmacy technician trainee (82) roles constituted the lowest numbers of persons registered in 2018.
Communication and Stakeholder Relations Our communication channels with the profession serve as service access points as we are largely a digitised organisation; as such, it is important that channels such as the Customer Care Centre, Walk-in Centre, and online application platforms operate to above industry-standard quality, efficiency and accessibility. The Customer Care Centre received 57 126 calls in 2018 and serviced 95,1% of these, indicating an increase in service levels of 4,1% to 95,1% in 2018 from 91,1% in 2017. While this is above the industry standard, we will continue to work tirelessly to move the service level closer to 100%. The Walk-In Centre attended to 2 377 customers during 2018 and achieved a first-time satisfaction rate of 89%. Usage of the online applications platforms for new service requests decreased by 1,1% from 81,3% in 2017 to 80,2% in 2018. I would like to urge pharmacy professionals and all our stakeholders to use the online application platform as not only does it improve case turnaround time but also ensures data integrity.
The online payments systems, which ensures instant allocation of funds and thus improves case turnaround times, continues to gain greater acceptance from stakeholders. The total value of online payments increased by 96,8% year-on- year, from about R7 million in 2017 to R13,7 million in 2018.
Media and public communication The efforts to bolster both stakeholder and public communication efforts continued at full-steam during 2018. Following our introduction of digital media channels to our communication efforts in 2017, the organic growth of
these has been reassuring. We have acquired more than 3 000 social media followers in the current reporting period, a number we hope to double in 2019.
In terms of media communication, we took opportunities provided by five media outlets to educate members of the public on various health issues and the work of the SAPC. Matters addressed included the codeine abuse challenge facing the country, antimicrobial stewardship, and our being at the forefront of implementing remote automated dispensing unit (RADU) technology in a manner that does not compromise patient safety and medicine efficacy.
We have also carried out an elaborate awareness campaign for Pharmacy Month, incorporating traditional media, social media networks and the official SAPC mouthpiece – the Pharmaciae. This followed hot on the heels of a successful Corporate Social Investment (CSI) programme at Wozanibone Secondary School, implemented with the support of various partners in Pharmacy.
A decade of clean, unqualified audits: Results of an uncompromising culture of good governance Good governance is more than just compliance with legislation; it is about doing the right things even when no one else is looking. We have consistently scrutinised our actions, transactions and operations against high ethical and moral standards for the past decade, to be able to deliver our tenth clean audit opinion. Moreover, our efforts to improve the liquidity ratio to ideal levels have paid dividends – the ratio grew from 0.98 in 2017 to 1.0 in 2018.
While we have managed to keep expenditure escalation within inflationary ranges, income remained relatively unchanged between 2017 and 2018. I would like to express my appreciation to the management collective, the outgoing Councillors and the staff in the Office of the Registrar for ensuring that, despite the turbulent economic times we operate in, the SAPC continues to weather the storm and deliver impeccably on its legislative mandate.
This is but a selection of achievements of the past year, what follows in the rest of this report is detailed updates on the operations of the SAPC in 2018.
TA Masango Registrar/CEO
The South African Pharmacy Council (SAPC) is an independent statutory body established in terms of the Pharmacy Act, 53 of 1974, as amended, to regulate the pharmacy profession. The SAPC is vested with statutory powers of peer review and embraces as its objectives those outlined in the Pharmacy Act.
The SAPC (hereinafter referred to as “Council”) is responsible for its own funding and endorses the principles contained in the King IV Report on Corporate Governance for South Africa. These principles form part of the councillors’ responsibilities and are embedded in the Charter for Councillors. Councillors are required to familiarise themselves with both the objectives of Council as outlined in the Pharmacy Act (henceforth “the Act”) and their responsibilities as outlined in the Charter for Councillors.
Council is representative of the profession and consists of 25 members, of which 16 are appointed by the Minister of Health, and 9 are elected by pharmacists.
Objectives and Functions of Council
In terms of the Pharmacy Act, 53 of 1974, Council’s objectives are to: • assist in the promotion of the health of the population of
the Republic of South Africa. • advise the Minister of Health or any other person on any
matter relating to pharmacy. • promote the provision of pharmaceutical care which
complies with universal norms and values, in both the public and private sectors, with the goal of achieving definite therapeutic outcomes for the health and quality of life of a patient.
• uphold and safeguard the rights of the general public to universally acceptable standards of pharmacy practice in both the public and private sectors.
• establish, develop, maintain and control universally acceptable standards for: - pharmaceutical education and training; - the registration of a person who provides one or
more or all of the services which form part of the scope of practice of the category in which such person is registered;
- the practice of the various categories of persons required to be registered in terms of the Act;
- the professional conduct required of persons registered in terms of the Act; and
- the control of persons registered in terms of the Act by investigating in accordance with the Act complaints or accusations relating to the conduct of registered persons.
• promote transparency to the profession and the general public in achieving its objectives, performing its functions, and executing its powers.
• maintain and enhance the dignity of the pharmacy profession and the integrity of persons practising the
profession. • coordinate the activities of Council and its committees,
give guidance to the Office of the Registrar, and provide oversight on risk management and financial controls.
• improve internal efficiency and effectiveness through improved customer care relations and service delivery, and investigation of alternative sources of funds.
• build a pipeline of highly skilled staff to meet the Council’s mandate through training, implementation of performance management and retention of key personnel.
Governance Structure
The Council is the custodian of the management and control of the profession and its meetings are public. Management and various committees support Council in carrying out its mandate.
Council Members (2013 – 2018)
The President presides over Council meetings and is supported by the Vice President and the Treasurer, both elected from members of Council by majority vote for a period of five years. The Registrar is the secretary for Council. The following is a list of councillors for the term 2013 - 2018.
Prof. Manoranjenni Chetty - President Mr Douglas James Heaslet Defty - Vice-President Ms Nocawe Portia Thipa - Treasurer Mr Vusi Cornelias Dlamini - Chairperson: Health Committee Mr Rajatheran Moodley - Chairperson: Committee of Informal Inquiries Ms Jacqueline Ann Maimin - Chairperson: Practice Committee Dr Panjasaram Naidoo - Chairperson: CPD Committee Mr Tshuba Solomon Rasekele - Chairperson: Committee of Preliminary Investigation Prof. Roderick Bryan Walker - Chairperson: Education Committee Mr Gavin Stewart Steel - Representative of the National Department of Health Prof. Shirley-Anne Inez Boschmans Mr Charles John Cawood Mr Johannes Stephanus Du Toit Ms Helen Catherine Hayes Ms Josephine Winley Herbert Ms Claudette Norina Jasson Mr Gaoboihe Jonas Kgasane Mr Panajiotaki George Kyriacos Ms Letty Mahlangu Mr Hezron Tshepo Mphaka Mr Johannes Albertus Raats (Adv.) Dr Nazreen Shaik-Peremanov Mr Matthys Jacobus Snyman Mr Ayanda Soka Ms Rachel Verity Wrigglesworth
Council – Role and Responsibilities
Newly elected/appointed Council Members (2018 – 2023)
The newly elected/appointed members of Council for the period 2018 to 2023 are:
Mr Mogologolo David Phasha - President Ms Boitumelo Molongoana - Vice-President Ms Nocawe Portia Thipa - Treasurer Prof. Yahya Essop Choonara Ms Pakama Dlwati Mr Johannes Stephanus Du Toit Dr Margaritha Johanna Eksteen Ms Helen Catherine Hayes Ms Josephine Winley Herbert Ms Khadija Jamaloodien
Mr Pieter Johannes Kilian Ms Mmapaseka Steve Letsike Ms Jacqueline Ann Maimin Prof. Sarel Francois Malan Dr Moliehi Matlala Ms Moitsoadi Sarah Mokgatlha Mr Tshegofatso Daniel Moralo Prof. Natalie Schellack (Adv.) Dr Nazreen Shaik-Peremanov Ms Tlou Mavis Shivambu Mr Mosiuoa Shadrack Shuping Mr Ayanda Soka Prof. Ilse Truter Ms Christina Aletta Venter Dr Petrus de Wet Wolmarans
Executive Committee
Seated: Vice-President: Mr Douglas James Heaslet Defty; President: Prof Manoranjenni (Mano) Chetty; Treasurer: Ms Nocawe Portia Thipa Standing: Chairperson CII: Mr Rajatheran (Sham) Moodley; Chairperson CPI: Mr Tshuba Solomon Rasekele; NDoH Representative: Mr Gavin Stewart
Steel; Chairperson Education: Prof Roderick Bryan Walker; Chairperson Practice: Ms Jacqueline Ann Maimin; Chairperson CPD: Dr Panjasaram (Vassie) Naidoo; Chairperson Health: Mr Vusi Cornelius Dlamini
Corporate Services
Strategic focus area
The activities of the Corporate Services Department focus on five of Council’s strategic objectives, being to; • assist in the promotion of health of the population of the
republic; • advise the Minister of Health or any other person on any
matter relating to pharmacy; • provide managerial and administrative support to the
Office of the Registrar; • coordinate the activities of Council by appointing
committees; and • promote transparency to the profession and the general
public.
Council meetings
Four Council meetings were conducted in February, May, July and October 2018.
Board notices
The Office of the Registrar published the following Board Notices during the year under review: (a) Board Notice 43, published on 23 March 2018 – Fees
payable to the Council under the Pharmacy Act, 53 of 1974 following adjustment in value-added tax (VAT)
(b) Board Notice 45, published on 6 April 2018 – Notice of election of members of the South African Pharmacy Council
(c) Board Notice 59, published on 11 May 2018 – Competency Standards for Pharmacists in South Africa
(d) Board Notice 82, published on 8 June 2018 – Notice of election of members of the South African Pharmacy Council (list of nominees)
(e) Board Notice 84, published on 15 June 2018 – Amendments to the Rules relating to Good Pharmacy Practice
(f ) Regulations relating to Continuing Professional Development, published on 13 July 2018 (for comment)
(g) Board Notice 99, published on 31 August 2018 – Minimum standards for unit dose dispensing (for comment)
(h) Board Notice 170, published on 2 November 2018 – Fees payable to the Council under the Pharmacy Act, 53 of 1974
(i) Board Notice 184, published on 21 December 2018 – Election/appointment of members of Council
Strategic plan 2014 – 2018
A presentation was made at the first Council meeting in February 2018 on the progress in terms of Council’s strategic plan for 2017, as well as the operational plans for 2018.
Operational plans 2018 and 2019
The Office of the Registrar held a Management Bosberaad on 22 and 23 November 2018 to discuss operational challenges during 2018, and to plan for 2019.
National/International Conferences
• Gauteng Pharmaceutical Services Conference, Birchwood Hotel & Conference Centre, Gauteng, 13 September 2018
• South African Association of Pharmacists in Industry (SAAPI) Conference, Bytes Conference Centre, Midrand, 14-15 October 2018
• Clicks Conference, Emperors Palace, Gauteng, 7-8 November 2018
• Gauteng Pharmacist’s Assistants Conference, St. Georges Hotel & Conference Centre, Pretoria, 9 November 2018
2018 Attendance at meetings
In terms of the principles of Corporate Governance and legal principles of administrative law, Council and Committee members must exercise their discretion in making decisions or providing recommendations to Council. This should be done within the confines of the Pharmacy Act and associated regulations.
The Council committees, appointed in terms of Section 4(o) of the Act, consider and discuss matters relevant to their portfolios as provided in various regulations, and provide recommendations to Council for consideration. Council makes decisions in terms of its general functions as contained in Section 4 of the Act, in consideration of the recommendations provided by various committees. In order for Council to be transparent to both the profession and public in achieving its objectives, performing its functions and exercising its powers, Council resolutions are published as a standard feature in each edition of the e-Pharmaciae.
For purposes of Corporate Governance, the attendance registers for 2018 Council and committee meetings are represented in the tables below:
Date of meeting Total members Present
Absent/ Apologies Both days One day
13-15 February 2018 25 23 0 2
16-17 May 2018 25 23 1 1
11-12 July 2018 25 19 1 5
10-11 October 2018 25 24 0 1 Table 1: Council meetings
Date of meeting Total members Present Absent/Apologies
8 March 2018 10 10 0
19 April 2018 10 9 1
16 May 2018 10 10 0
7 July 2018 10 7 3
23 August 2018 10 7 3 Table 2: Executive Committee meetings
12 March 2018 9 8 1
4 June 2018 9 6 3
13 August 2018 9 7 2 Table 3: Continuing Professional Development (CPD) Committee meetings
13 March 2018 12 10 2
5 June 2018 12 10 2
14 August 2018 12 9 3 Table 4: Education Committee meetings
14 March 2018 13 9 4
4 April 2018 (Special Teleconference) 13 7 6
6 June 2018 13 11 2
15-16 August 2018 13 13 0
13 September 2018 (Special meeting) 13 9 4 Table 5: Practice Committee meetings
15 March 2018 5 5 0
7 June 2018 5 4 1
17 August 2018 5 4 1 Table 6: Health Committee meetings
20-21 February 2018 5 4 1
17-18 July 2018 5 4 1 Table 7: Committee of Informal Inquiries (CII) meetings
6-7 March 2018 7 6 1
24-25 July 2018 7 5 2 Table 8: Committee of Preliminary Investigation (CPI) meetings
27 March 2018 3 3 0
31 May 2018 3 3 0
4 September 2018 3 3 0 Table 9: Committee of Formal Inquiries (CFI) meetings
24 April 2018 7 6 1
7 August 2018 7 6 1
13 November 2018 5 5 0 Table 10: Audit Committee meetings
13 June 2018 4 4 0 Table 11: Trustees Committee meeting
18 April 2018 4 4 0
12 September 2018 4 4 0
28 November 2018 4 4 0 Table 12: Bargaining Committee meetings
17 April 2018 4 4 0
11 September 2018 4 4 0
27 November 2018 4 4 0 Table 13: REMCO Committee meetings
1 March 2018 2 2 0
10 May 2018 2 2 0 Table 14: Tender Committee meetings
Corporate Services Amos Masango (Registrar/CEO); Vincent Tlala (COO); Anelda Gillmer (PA to CEO); Letty Mathebe (PA to COO); Thelma Sealetse
(Logistics Travel Coordinator); Lynette Malan (Logistics Travel Coordinator)
Public and media communication for the 2018 reporting period was constituted largely by the 2018 Pharmacy Month campaign, which enjoyed wide media coverage from national, regional and community media across South Africa, and communication of Council’s corporate social investment endeavours during Mandela Month (July 2018).
In addition to proactive media and public communication, the Office of the Registrar received and replied to various media enquiries from both international and local media establishments.
The issues of engagement ranged from the finalisation of the scope of practice for Pharmacy Technician graduates and the impact the delay is having on their lives to the implementation of Remote Automated Dispensing Units (RADUs) and the perceived shortage of pharmacists in the country. Abuse of over-the-counter codeine-containing cough medicine also took centre stage, with the Office of the Registrar being invited to discuss this scourge on an investigative journalism programme.
The activities of the Communication and Stakeholder Relations (CSR) Department focus on four of Council’s strategic objectives, which are to: • assist in the promotion of the health of the population of the
Republic of South Africa; • advise the Minister of Health or any other person on any matter
relating to pharmacy; • promote transparency to the profession and the general public
(corporate governance); and • provide managerial and administrative support to the Office of the
Registrar.
In line with the above strategic focus areas; the department is responsible for public and media relations, general communication and publication- related activities for both internal and external stakeholders. In addition, the department manages Council’s customer and logistics services.
Corporate Communication
3rd National Pharmacy Conference The 3rd National Pharmacy Conference (3rd NPC) will be held at Sun City, North West from 3 to 5 October 2019. As with the 2013 and 2016 conferences, it is planned that the conference be funded from delegates’ registration fees, sponsorships and exhibitors at the conference.
The 3rd NPC website went live on 30 April 2018, immediately allowing interested persons to register as delegates and settle registration fees in instalments over fourteen months, until 31 July 2019. The website content was developed in consultation with Council’s Steering Committee on the National Pharmacy Conference.
Communication to promote the conference to prospective delegates, sponsors and exhibitors began in May 2018.
In order to raise funds to host the conference, the Office of the Registrar hosted two sponsorship breakfast meetings with various prospective sponsors on 17 and 19 July 2018, in Johannesburg and Cape Town respectively.
To ensure that the programme for the 3rd NPC responds to the career development needs of the profession, young South African pharmacists and pharmacy support personnel were invited to complete a short online survey through which they could indicate what topics they felt needed to be addressed at the conference. Input received from the survey was duly considered when compiling the programme for the 3rd NPC.
2018 Council Elections An elaborate communication programme encompassing social media, email and SMS campaigns saw the participation slightly increase, from 18,8% in the 2013 Council Elections to 20,3% in the 2018 Council Elections. The Office of the Registrar also responded to media enquiries on the election process.
SAPC website
The website recorded a total of 803 091 sessions during 2018, with new visitors comprising 27,03% of that number. This resulted in 4 894 096 public website page views, thus averaging six (6) pages per session. The secure login site recorded 341 373 logins in 2018.
Communication and Stakeholder Relations
Public and media relations
Recorded logins by category 2017 2018
Provider/Employer Administration 15 504 13 250
SAPC – Organisations 6 436 5 279
SAPC – Registered Persons 308 084 322 844 Table 15: Logins recorded per category
Social & Digital media
Over the period under review, the South African Pharmacy Council established official accounts across all popular social media networks: Facebook, Twitter, Instagram and LinkedIn, in order to improve communication to the profession and all stakeholders. The Office of the Registrar has managed to increase audience numbers across all social media accounts organically, with zero budgetary implications. The total audience across all social media grew from zero to 2 855 in 2018, and post reach for the period under review was more than 100 000 impressions.
The development of a device responsive website was concluded in 2018. This milestone will result in improved user experience and improved access to Council information as the website can now be virtually accessed from any fit-for-purpose communication device.
2018 Pharmacy Month
In its second year since superseding National Pharmacy Week, the Pharmacy Month campaign was this year observed from 1 to 30 September. The main theme for the 2018 Pharmacy Month was “Towards Quality Care Together – Use Medicines Wisely”. The campaign encouraged patients to use medicines with care and to always speak to their pharmacist when in doubt.
Several campaign materials were developed and distributed to all responsible pharmacists across the country. A media release was issued to all media houses in South Africa and shared with major news agencies.
Pharmacy Month messages were featured in more than 40 media articles and interviews throughout September. Social media was also abuzz with posts and messages from the pharmacy profession using the official hashtags #PharmacyMonth, #UseMedicinesWisely, and #AskYourPharmacist. Through the hashtags, pharmacists across the country were able to instantly share their community activities with all stakeholders and increase awareness about Pharmacy Month to the South African public.
The theme for Pharmacy Month 2018 was “Use Medicines Wisely” with four sub-themes: (a) Know your medicine; (b) Store your medicines correctly; (c) Travel safely with your medicines; and (d) Talk to your pharmacist.
A Town Hall Meeting was held with the staff of Council to discuss Pharmacy Month. Ms Jackie Maimin, as the Chairperson of the Practice Committee, led the discussion which was live-streamed on the Official SAPC Facebook page. Messages relating to the theme for the month, as well as the sub-themes, were published on Council’s various social media platforms and were well received.
In comparison to previous years, the 2018 Pharmacy Month campaign was a major success in terms of media coverage. With more preparation and effort, Council aims to massively increase the coverage and awareness around Pharmacy Month in the coming years.
Publications
Two issues of the e-Pharmaciae were published during the period under review. As the flagship publication of the South African Pharmacy Council, each edition of the e-Pharmaciae carries important Council decisions and other information affecting the practice of pharmacy in the country to ensure that pharmacy professionals are always kept in the loop of key developments in the industry.
Outlined below is the analytics of the August and December 2018 e-Pharmaciae editions. Market research shows that with each bulk e-campaign, only 30% of emails are opened. The August 2018 e-Pharmaciae beat this market ratio by 6,8% and the December 2018 issue beat the ratio by a whopping 10,55%.
Analyses August 2018 data December 2018 data
1. Emails sent 35 319 35 647
2. Emails opened 36,8% 40,55% Table 16: e-Pharmaciae 2018 statistics
The 2017 Annual Report was published in October 2018.
Internal communication
The Department executed several poster campaigns and email e-notes in order to communicate key information to Council staff members in order to support operational objectives. Additionally, one town hall format meeting was held wherein staff were educated on the themes of Pharmacy Month so as to motivate the staff members to be ambassadors for the initiative in their communities. The development of an intranet site in order to integrate employee relations, encourage collaboration, and ensure seamless internal communication is in the final stages.
Language Support
Increased internal capacity in copy editing has resulted in 65 documents being edited internally over the period. The Department has engaged in both grammatical and substantive editing of documents ranging from stakeholder correspondence to standard documents and board notices amongst others.
Corporate Social Investment
On Friday, 17 August 2018, the staff in the Office of the Registrar embarked on an outreach programme at Wozanibone Interim Farm School in the east of Tshwane to help alleviate some of the challenges the learners at the school endure due to poverty and lack of resources, on behalf of all in the pharmacy profession. The Office of the Registrar repaired school premises and donated sanitary towels, toiletries, school shoes, stationery, school uniform items and food items. The donations were made possible by generous contributions from Boagi Projects, Clicks, Dis-Chem Pharmacies, E2 Solutions and the Independent Community Pharmacy Association.
Media coverage of the event increased brand exposure for the South African Pharmacy Council, with the outreach event being featured in a prime time newscast, and in online and print media.
The Principal and the parents expressed gratitude to Council for having touched their children’s lives in a positive way.
Stakeholder Relations SAPC IP PBX self-help functionality
The self-help functionality on VOIP-PBX to enhance customer service
experience when telephoning Council was introduced in 2014.
Customers are now able to interactively request Council’s banking
details, their login passwords on the secure site and their individual
financial statements. Table 17 below shows VOIP-PBX usage comparison
for 2017 and 2018.
2017 2018
Login passwords 191 288
Financial statements 1 449 397 Table 17: Usage of Council’s IP PBX self-help functionality 2018 comparison with 2017
Online application and payment functionality
Online payments
During 2018, online payment transactions totalled R13 722 576,14; representing an increase of 50,8% compared to the previous financial year. A total of 4 182 pharmacy professionals used the online payment portal in 2018.
Online applications
Since December 2014, the online completion and submission of the majority of applications became mandatory. A comparative breakdown of the online submission of applications between 2015, 2016, 2017 and 2018 is shown in Table 18 below:
Customer Satisfaction Survey
Category of application 2015 2016 2017 2018 Application for approval of premises to train interns and assistants 160 145 162 68 Application for approval of a tutor for the purpose of training 1 055 2 056 1 315 984 Application for extension of registration 0 1 13 13 Application for Pharmacist Assistant Learner Basic 1 544 1 820 1 726 1 488 Application for Pharmacist Assistant Learner Post Basic 1 841 1 533 1 331 1 218 Application for Pharmacy Technician Student (Advanced Certificate) 78 5 5 Application for Pharmacy Technician Student (Higher Certificate) 135 117 129 Application for pre-registration exam 4 32 88 77 Application for the recording of new pharmacy premises 19 377 345 291 Application for registration as a Community Service Pharmacist 394 614 521 452 Application for registration as an intern 601 786 331 357 Application for registration as a pharmacy technician (Post-basic assistant) 0 0 53 53 Application for registration as a PT trainee 25 54 76 72 Application for registration as a PTA trainee 3 3 0 4 Application for registration as the Responsible Pharmacist 507 697 587 558 Application for review of pre-registration examination paper in terms of the Pharmacy Act, 53 of 1974 0 0 14 8 Application for student (BPharm) 1 207 1 054 1 044 PCDT permit 0 20 32 20 Person- entrance to professional examination for purposes of registration as a pharmacist (per paper) 0 3 0 Pharmacist’s assistant – change of pharmacy 0 0 143 146 Pharmacist’s assistant – change of provider 0 0 19 27 Pharmacist’s assistant – change of tutor 0 0 278 309 Pharmacy premises application for licensing 0 17 46 112 Scheduled inspection/evaluation of a pharmacy for purposes of approval for training 504 836 556 319 Supplementary training certificate – PCDT/Family planning 0 3 11 19 Total 8 077 10 173 8 825 6 595
Table 18: Number of online applications submitted in 2015, 2016, 2017 and 2018
Figure 1: Overall satisfaction rating of Council’s online functionality in 2018
Instant messaging and e-messages • SMS automated messages sent from the website and the register system: A total of 266 214 SMSes were sent out • SMS campaigns: A total of 150 124 SMSes were sent out. These are inclusive of automated responses sent from the dashboard and customised SMSes from
the Contact Centre. • Bulk e-mail campaigns: A total of 28 different bulk e-campaigns were conducted during 2018.
Service Delivery Survey
Service Delivery Ratings
2016 2017 2018
Excellent/Good 33% 35% 36%
Average 24% 22% 21%
Poor 43% 46% 43% Table 19: Service delivery rating comparison 2016, 2017 and 2018
Contact Centre
Number of incoming calls 70 660 66 625 57 126
% of Calls Serviced 88,7% 91,1% 95,2% Table 20: Contact Centre service rating comparison 2016, 2017 and 2018
Excellent/Good 66%
Average 12%
Poor 22%
Front desk and pre-audit of manual applications
Of the 16 522 cases received during the period under review, 3 268 were created manually, while the balance of 13 254 were created online. The improved online functionality and the profession’s use thereof have decreased the number of incoming manual cases considerably.
The Logistics Unit validated 1 922 applications during 2018. Of the total number of applications, 1 912 complied with Council’s requirements and were, after validation, escalated to the technical departments for immediate processing. A total of 10 applications required a follow up for outstanding documentation.
The Office of the Registrar attended to 2 377 walk-in customers during 2018. This is how they rated the service received at the walk-in centre:
Logistics Centre
The unit scanned in 6 659 documents. In addition, a total number of 1 337 grading certificates were printed, scanned and couriered. A further 8 911 certificates and registration documents were printed and couriered. A total of 15 574 items were couriered and 2 048 items posted by EDBN mail. A total of 42 184 PODs were issued and uploaded on the Register system.
ID registration cards
Council’s registration cards are fitted with security and barcode features with ID passport photos. From printing to shipping, the process is in-house, which simplifies the handling of communication queries. A total of 11 778 ID registration cards were issued in 2018. Of this total 8 140 cards were printed in-house for inter alia basic assistants, post-basic assistants and pharmacists and 3 648 cards were issued during student visits.
Figure 2: Overall satisfaction rating of Council’s online functionality in 2018
Communications & Stakeholder Relations Elmari Venter (Senior Manager: CSR); Michelle de Beer (Manager:
Stakeholder Relations); Madimetja Mashishi (Manager: Communication and Media); Brian Baloyi (Stakeholder Relations Practitioner); Thembi Shabangu (Logistics Practitioner); Natalie
Urban (Communications and Media Practitioner); Jermina Matlaila (Secretarial Support Officer); Stephina Mogotsi (Contact Centre
Agent); Zanele Masombuka (Contact Centre Agent); Mpho Marole (Contact Centre Agent); Tebogo Mnisi (Contact Centre Agent); Audrey
Mathekga (Contact Centre Agent); Mpho Musi (Contact Centre Agent); Phumzile Sonyamba (Contact Centre Agent); Zeodie Felix (Contact Centre Agent); Neo Ramokoka (Contact Centre Agent); Tebatso Moukangoe (Contact Centre Intern); Thembi Maboho
(Logistics Clerk); Violet Mothupi (Logistics Clerk); Betty Thubane (Logistics Clerk); Sinah Mabje (Logistics Clerk); Johannes Mosetlha (Logistics Officer); Tshiriletso Mokono (Logistics Clerk); Nicole Furst
(Logistics Officer); Abram Moropa (Logistics Clerk)
The activities of the Professional Affairs: Practice Unit focus on four of Council’s strategic goals, which are to:
• promote the provision of pharmaceutical care, which complies with universal norms and values in both the public and the private sectors, with the goal of achieving definite therapeutic outcomes for the health and quality of life of a patient;
• uphold and safeguard the rights of the general public to universally acceptable standards of pharmacy practice in both the public and private sectors;
• establish, develop, maintain and control universally acceptable standards of practice in the various categories of persons required to be registered in terms of the Pharmacy Act, as well as the promotion of the provision of pharmaceutical care; and
• establish, develop, maintain and control universally acceptable standards of practice in the professional conduct required of a person registered in terms of the Pharmacy Act.
Practice Committee
The Practice Committee held five meetings including one teleconference with Ms Jackie Maimin as chairperson.
During this period, the committee developed new standards, reviewed some existing standards, reviewed inspection questionnaires, discussed reports on Good Pharmacy Practice (GPP) recommendations for the Director-General: Health to issue pharmacy licenses and section 22A(15) permits issued in terms of the Medicine and Related Substances Act, 101 of 1965.
Standard setting
The Rules relating to Good Pharmacy Practice (GPP) standards were last published in 2010 and were reviewed in 2018 to incorporate all standards published for implementation by Council up to and including 2017. The revised GPP is now available on the SAPC website.
On 25 August 2017, the Minister of Health, in consultation with the South African Health Products Regulatory Authority (SAHPRA) published the General Regulations under the Medicines and Related Substances Act, 101 of 1965, and replaced/repealed the General Regulations published on 10 April 2003. As a result of the changes to the General Regulations in 2017, Council is in the process of updating the GPP to ensure consistency with the General Regulations. Council will publish these corrections in a board notice during 2019. As from 25 August 2017, where the GPP makes reference to the General Regulations, the General Regulations will take precedence.
Minimum standards for the sale of HIV self-screening test kits
The Minimum standards for the sale of HIV self-screening test kits, published for implementation on 17 November 2017 (Board Notice 184), will be included in the GPP during the publication of the correction board notice.
Professional standards for services offered from a pharmacy
Council approved the creation of Chapter 5 of the GPP. This chapter will focus on professional services offered from a pharmacy, while Chapter 2 focuses on services offered in a pharmacy. This is in line with the
definition of a pharmacy in the Pharmacy Act, 53 of 1974, referred to as “any place wherein or from which any service specially pertaining to the scope of practice of a pharmacist is provided.” Some of the standards already published in the Rules which are intended to address services offered from a pharmacy will be moved to this chapter.
The final document, that is, the Rules relating to Good Pharmacy Practice, would have the following chapters:
Chapter 1: Professional standards for premises Chapter 2: Professional standards for services Chapter 3: Professional standards for pharmacy human resources Chapter 4: Professional standards for pharmacy management Chapter 5: Professional standards for services offered from a pharmacy
A correction board notice for the amendment of the GPP to include Chapter 5 will be published in 2019 for implementation.
Minimum standards for unit dose dispensing
The Minimum standards for unit dose dispensing (UDD) was published for comment (BN 99/2018) on 31 August 2018 as an additional standard in the GPP in accordance with section 35A(b)(ii) of the Pharmacy Act, 53 of 1974. The closing date for the comments was 31 October 2018. Stakeholders submitted comments for review by the Practice Committee in 2019.
The standard defines UDD as a process where individual doses of different medicines are dispensed or re-dispensed into a container, ready for administration to patients, involving a manual or an automated system and that includes, but is not restricted to, other international definitions, e.g. the multi-compartment system.
Minimum standards specifically relating to UDD and the use of unit dose containers are intended to guide pharmacists and pharmacy support personnel on the legal requirements to be taken into consideration when dispensing or re-dispensing medicines in a container as individual unit doses.
Professional Affairs – Practice
Minimum standards for locum tenens pharmacists and pharmacy support personnel
The Practice Committee reviewed Rule 3.5: Minimum standard for locum/relief pharmacists published in the Rules relating to Good Pharmacy Practice. The standard addresses information that must be made available to the locum/relief pharmacist to ensure that there is a continuous provision of pharmaceutical services and compliance to GPP.
The review follows the gap identified by the Committee of Preliminary Investigation with regards to the information and recordkeeping in use by locums as part of the required documentation to be legally kept by the pharmacy. It became apparent that responsible pharmacists do not always keep records of locum/relief pharmacists and this creates a challenge when Council receives allegations of misconduct in a pharmacy that was under the supervision of a locum/relief pharmacist.
Amongst the proposed changes made was the renaming of the standard from Minimum standards for locum/relief pharmacists to Minimum standards for locum tenens pharmacists and pharmacy support personnel, as well as the addition of a statement that reads, “the responsible pharmacist must be able to demonstrate which registered persons were in the pharmacy at any particular time on any day in terms of the requirement for recordkeeping.”
The standard was approved by Council on 10/11 October 2018 to be published for comment. The standard will be published for comment during 2019.
Minimum standards for pharmacy administration and management
The Practice Committee reviewed Rule 4.2: Minimum standards for pharmacy administration and management published in the GPP. The standard was initially developed to optimise the quality of pharmaceutical services rendered in pharmacies which include lists of SOPs that must be in each category of pharmacy.
As a result of the changing pharmacy environment, the Practice Committee saw the need to review the list of SOPs that must be available in each category of pharmacy. In the reviewed standard additional SOPs are added and those that were considered obsolete were removed. The SOPs were grouped together according to broad categories, i.e. services, human resources, premises and management, and a list is to be generated under each category of pharmacy, i.e. community, wholesale, etc.
The standard was approved by Council during its 10/11 October 2018 sitting to be published for comment in 2019.
Minimum standards for alternative models for the delivery of medicines
The need to develop standards for alternative models for the delivery of medicines is in response to a report of the meeting between the Minister of Health, the MEC’s of Health and the South African Pharmacy Council (represented by the President of Council), held on 22 August 2014 at the National Department of Health.
Following the discussion of the report, Council resolved that the minimum standards for alternative models of delivery of chronic medicines be developed to extend services to patients, especially in rural areas, for as long as it is within the confines of the law.
Council developed a document titled Requirements and conditions for the evaluation of alternative models of delivery of chronic medication to
patients in an attempt to address some of the questions and requests from stakeholders who wished to extend pharmaceutical services to areas of need or to provide services from a pharmacy as per the definition of a pharmacy in the Pharmacy Act. The document was approved by Council in 2017 and published on the SAPC website. Council intends to include this document in the Rules relating to Good Pharmacy Practice in 2019.
Council appointed a task team to assist the Practice Committee in developing the two standards for alternative models for the delivery of medicine to address the dire need for expanding access to pharmaceutical services. The task team met five times in 2018 to develop these standards. These standards are:
(a) Minimum standards for Pharmacy-Linked Distribution Facilities (PLDF); and
(b) Minimum standards for outreach pick-up points (PuP) of medicines for patients who have been stabilised on long-term therapy and utilising a centralised medicine dispensing and distribution (CCMDD) programme.
The Minimum standards for PLDF, previously known as the ‘Minimum standards specifically relating to the approval of facilities (other than primary healthcare clinics) where a pharmacist’s assistant (post-basic) may practice under indirect supervision – pharmacy linked distribution points’, was initially developed in 2017 and published for comments. The comments received were of such a nature that Council had to re-write the standard and develop another standard called Minimum standards for outreach PuP of medicines for patients who have been stabilised on long-term therapy and utilising a CCMDD programme.
The Minimum standards for PLDF were developed with Regulation 12 of the Regulations relating to the practice of pharmacy in mind. Regulation 12 provides that a pharmacist’s assistant (post-basic) may perform the acts or provide the services as prescribed in sub-regulations 11(5), 11(6), 11(8) and 11(9), as well as the reading and preparation of a prescription, the selection, manipulation or compounding of medicine and the labelling and supply of medicine in an appropriate container under the indirect personal supervision of a pharmacist, provided that the services are provided or acts are performed at a primary healthcare clinic or any other facility as approved by Council.
During its meeting of 10/11 October 2018, Council resolved that these standards be referred to the new Practice Committee for finalisation in 2019. This resolution was concurred with by the Executive Committee (EXCO) at its meeting of 18 October 2018.
Another business or practice in a pharmacy
On 17 December 2014, Council published the Minimum standards for premises, facilities and equipment (Board Notice 35 of 2012) for implementation. The standard has two sections:
(i) Section 1.2.2.1 – A pharmacy in another business; and (ii) Section 1.2.2.2 – Another business or practice in a pharmacy.
The criteria for approval of another business or practice in a pharmacy was developed and approved by Council in 2016.
In 2017, the Practice Committee reviewed Rule 1.2.2.2 to ensure that the standard appropriately incorporated the Medirite v South African Pharmacy Council (197/2014) [2015] ZASCA 27 (20 March 2015) judgment and other provisions which were not directly affected by the judgment. The reviewed documents will be finalised by Council in 2019 and if approved, published for comments.
Board Notice 84 of 2018, published on 15 June 2018, repealed Board Notice 35 of 2012 in its entirety in so far as it related to Rule 1.2.2 of the GPP (Another business or practice in a pharmacy or a pharmacy in another business), while Council is still applying itself on Board Notice 35.
Minimum standards relating to the supervision of pharmacy support personnel
Regulation 14 of the Regulations relating to the practice of pharmacy prescribe that a pharmacist may not – (i) have under his or her direct personal supervision more than three
pharmacist’s assistants in a pharmacy; or (ii) subject to Regulation 12, have more than five pharmacist’s assistants
(post-basic) under his or her indirect personal supervision.
Council published Board Notice 271 of 2013 on the Minimum standards relating to the supervision of pharmacy support personnel (PSP). According to 4.7 of the standard document, a pharmacist may supervise a maximum of three pharmacy support personnel, inclusive of qualified personnel and those who are undergoing training. A pharmacist may supervise a combination of pharmacy support personnel with different role types.
The Practice Committee has noted submissions from wholesale pharmacies and other stakeholders requesting increased ratios of PSPs to pharmacists to ensure that all persons handling medicines are registered with Council. The current Regulations relating to the practice of pharmacy limit the number of supervised personnel to three, and therefore, Council has found it difficult to honour these requests in the past. The Regulations relating to the practice of pharmacy are being reviewed, and once finalised, Council will revisit amendments to the standard.
Survey for reference sources that must be accessible in each category of pharmacy
An online survey was conducted to establish reference sources that must be accessible in each category of pharmacy. The survey was released for completion by all registered persons from 5 October to 16 November 2018. Council still needs to interrogate the data and conduct further literature research for international benchmarking prior to publishing proposed changes in terms of the reference materials that must be accessible in each category of pharmacy. The profession will be granted an opportunity to comment on Council’s proposed changes prior to implementation.
Pharmacy Inspectors (Council Officers)
Since 1 November 2017, six additional Council Officers have been appointed, that is, three for Gauteng and one each for the Western Cape, KwaZulu-Natal and Mpumalanga.
Of the 27 Council Officers appointed in previous years, two (2) were not reappointed.
The remaining 25 Officers, along with the six (6) new appointees, signed a service level agreement (SLA) with Council which expired at the end of 2018. Two training sessions were conducted in March and May 2018. During these training sessions previous Council decisions affecting inspectors, expectations of Council from inspectors and the inspection questionnaires were discussed. Inspectors had an opportunity to provide input on the inspection questionnaires to improve pharmacy inspection outcomes and to eliminate subjectivity.
Towards the end of 2018, a bosberaad (intensive workshop) was conducted over two days, where the Office of the Registrar presented the operational plans for 2018. The 2019 operational plans were also
finalised at this meeting. The chairpersons of the Practice Committee and the Committee of Preliminary Investigation, representatives from the National Department of Health and SAHPRA, as well as all the heads of department within the Office of the Registrar addressed the inspectors on various issues affecting them and the practice of pharmacy as a whole.
Pharmacy Inspection Tool (Inspection questionnaires) and grading of pharmacies
When the grading system was introduced in 2013, it was envisaged that over time, all sections will be weighted equally as the GPP recognises all sections as equally important. At the inception of grading in 2013, sections within the inspection questionnaires were weighted differently, with the weighting ranging from 1 to 7. The table below summarises the weighting explanation:
Weightage key
2 Less important
3 Slightly important
4 Neutrally important
5 Moderately important
6 Very important
7 Extremely important Table 21: Inspection weighting key
Council appointed a task team and the North-West University (NWU) in 2017 to assist the Practice Committee in reviewing the inspection questionnaires and grading of pharmacies. The task team met three times in 2018 and presented their report at each Practice Committee meeting.
All the 2018 inspection questionnaires (five categories of pharmacy) were revised and approved by Council on 10/11 October 2018.
To review the grading an electronic scoring matrix was developed to assist role players in assigning weights and compliance values to various sections in the inspection. A survey to do the above was conducted using the electronic scoring matrix and the following role players participated in the survey:
(i) SAPC inspectors – implementers of the inspection questionnaires; (ii) SAPC staff members – evaluators of the inspection questionnaires; (iii) Practice Committee members – decision-makers with regard to the
inspection questionnaires; and (iv) Heads of pharmaceutical services (Groups, Metros and Provincial)
and heads of professional associations – representatives of the profession.
On presentation of the results of the revised grading methodology to NWU statisticians for analyses, the office was advised to include responsible pharmacists as part of the role players to increase the sample size, and then submit the reviewed methodology to NWU’s Committee for Scientific Review, thereafter to the Ethics Committee for approval and allocation of an ethics number.
The roll-out process for review of grading, implementation of the computer application for inspections (“Inspection App”) being developed, as well as the 2018 inspection questionnaires will be communicated to stakeholders once approved by Council.
Council intends conducting workshops in 2019 to communicate all these changes to responsible pharmacists and interested persons.
Inspections of pharmacies
A total of 1 815 inspections were conducted by the end of December 2018. These included monitoring, training, new pharmacies and disciplinary inspections. Figures 3 and 4 provide a summary of inspections conducted in 2018 and their grading by province and category of pharmacy registration.
Grade A pharmacies are considered ‘excellent’. Minor deficiencies would have been observed during an inspection. Where major deficiencies were observed during an inspection, the pharmacy will attain Grade B, and be considered as ‘good’. Grade C pharmacies are those with critical deficiencies observed during an inspection. These pharmacies are inspected annually, and the owner is required to pay the cost of the inspection. The fee to be paid by the owner is published via Board Notice, which is accessible on the SAPC website.
The majority (80%) of the inspections conducted were monitoring inspections. Other inspections conducted were new pharmacy inspections, training inspections, disciplinary inspections and inspections conducted as a result of owner requests. New pharmacy inspections are conducted after the recording of a new pharmacy and the recording of a license after a change of ownership or relocation.
There were no inspections conducted for consultant pharmacies.
Figure 4: Pharmacy inspections conducted in 2018 and their grading by category of registration
Figure 3: Pharmacy Inspections conducted in 2018 and their grading by province
Eastern Cape Free State Gauteng KwaZulu Natal Limpopo Mpumalanga Western CapeNorth West Northern Cape
Previously the community pharmacy questionnaires were used to inspect these facilities although the services are not similar. Council approved a new inspection questionnaire in line with the services to be provided by this category of pharmacy. The online system is being reviewed to accommodate this change. Effective from 2020, consultant pharmacies will be inspected using the newly developed questionnaire.
Good Pharmacy Practice recommendations: Licensing and recording of pharmacies
A total of 515 licence applications were evaluated and finalised during 2018. The National Department of Health issues licenses where GPP requirements are satisfactory and the application complies with the Regulations relating to the ownership and licencing of pharmacies. Figure 5 below provides a summary of licence applications evaluated for GPP compliance.
A project to issue licences to all owners who opened their pharmacies prior to May 2003 was initiated during 2018. Letters were sent to all pre-May 2003 owners to communicate this intention of Council. Two meetings were held with the National Department of Health Affordable Medicines Technical Unit to discuss the approach and technicalities around this project.
On 16/17 May 2018, Council resolved that owners who wish to convert from a close corporation (CC) to a private company (Pty (Ltd)) apply for a change of ownership and the Council decision further states that a reduced fee be levied to owners who apply for change of ownership whose pharmacies are Grade A at the time of recording.
The changes from CC to private company for many pharmacy owners were as a result of the new Companies Act, 71 of 2008, which made provision for the phasing out of the juristic person identified and registered as a close corporation. As a result, the registration of close corporations was phased out. Council was informed that all close corporations must convert from the juristic person to a private company; however, on further investigation, it was established that the conversion of all close corporations to private companies was not compulsory.
About 300 of the licenses issued were recorded with Council in 2018, see Table 22. Some of the licenses recorded were issued in previous years while others are still to be recorded in 2019. Council is in the process of strengthening compliance to Regulation 8 of the Regulations relating to the ownership and licensing of pharmacies which mandates all pharmacy owners to record their licenses with Council within 30 days of being issued.
Category of pharmacy Number
Wholesale Pharmacy Private 16
Grand Total 300 Table 22: Licenses recorded per category of pharmacy
Good Pharmacy Practice recommendations: Section 22A(15) permit recommendations
Section 22A(15) of the Medicines and Related Substances Act, 101 of 1965, states that –
“the Director-General may, after consultation with the Interim Pharmacy Council of South Africa as referred to in section 2 of the Pharmacy Act, 53 of 1974, issue a permit to any person or organisation performing a health service, authorising such person or organisation to acquire, possess, use or supply any specified Schedule 1, Schedule 2, Schedule 3, Schedule 4 or Schedule 5 substance, and such permit shall be subject to such conditions as the Director-General may determine.”
Council evaluates and makes recommendations on these applications for the Director-General to issue permits. A total of 106 Section 22A(15) permit applications were evaluated and finalised as summarised in Figure 6 below:
Figure 5: Pharmacy licence applications evaluated in 2018
Recommendations in terms of Section 56(6)(d) of the Nursing Act, 33 of 2005
Section 56(6)(d) of the Nursing Act, 33 of 2005, states that, despite provisions of this Act, the Medicines and Related Substances Act, 101 of 1965, the Pharmacy Act, 53 of 1974, and the Health Professions Act, 56 of 1974,
“a nurse who is in the service of –
Organisation: Granting Authority:
The national department Who has been authorised by the Director- General
A provincial department of health Who has been authorised by the head of such provincial department of health
A municipality Who has been authorised by the medical officer of health of such municipality
An organisation performing any health service designated by the Director-General after consultation with the South African Pharmacy Council referred to in section 2 of the Pharmacy Act
Who has been authorised by the medical practitioner in charge of such organisation
as the case may be, may in the course of such service perform with reference to –
(i) the physical examination of any person; (ii) the diagnosing of any physical defect, illness or deficiency in any
person; or (iii) the keeping of prescribed medicines and their supply, administering or
prescribing on the prescribed conditions;
any act which the said Director-General, head of provincial department of health, medical officer of health or medical practitioner, as the case may be, may, after consultation with the Council, determine in general or in a particular case or in cases of a particular nature, if the services of a medical practitioner or pharmacist, as the circumstances may require, are not available.”
The applications from the public sector are mostly supported by the
local authorities and are aimed at improving access to pharmaceutical services in areas of need.
Four applications for approval for designation as a health service- rendering organisation were evaluated and finalised. These were:
• Saheti School • University of Pretoria • Wellness Health Outcomes (Pty) Ltd • St. Mary’s Diocesan School
Council has since written a letter on 19 December 2017 to the Director- General: Health expressing concerns regarding the use of section 56(6)(d) of the Nursing Act in the private sector, and requesting that the Director-General: Health formulate a policy for designation of establishments in terms of section 56(6)(d) where such organisations are in the private sector. Council awaits feedback from the Director- General: Health on this matter.
Other matters discussed by the Practice Committee
(a) Issuing of section 22A(15) permits to pharmacists who have completed supplementary training on pharmacist-initiated PrEP (Council minutes 11/12 July 2018).
(b) Approval of a mandate for Council to inspect applicants for section 22A permits prior to issuing a permit. Council may levy a fee for these applications equivalent to the cost of the inspection (Council minutes 11/12 July 2018).
(c) Limitations on pharmacy licenses issued for different categories of pharmacies.
(d) Meeting to discuss concerns about registered persons performing the scope of practice of a pharmacist in facilities not registered with Council (Managed health care facilities to be registered as consultant pharmacies).
(e) HPCSA: Regulations defining the scope of the profession of radiographers, clinical associates and podiatrists.
Figure 6: A summary of Section 22A(15) permit applications evaluated
Premises approval for the training of pharmacist interns and pharmacy support personnel
About 680 of the applications submitted to Council in 2018 for premises approval for training interns and pharmacy support personnel were approved. These brought the total number of premises approved in 2018 to 2 325, as per Table 23 below:
Approved in 2018 Total approved
Academic Institution 3 9
Institutional Private 50 185
Institutional Public 123 408
Manufacturing Pharmacy 14 45
15 51
Grand Total 680 2 325 Table 23: Premises approvals in 2018
Meetings facilitated by the Practice Unit
The Professional Affairs: Practice Unit facilitated two stakeholder forum meetings. The purpose of these meetings was to communicate Council
decisions and to engage with stakeholders on matters of professional interest. The meetings were attended by members of different professional associations and heads of pharmaceutical services.
As part of Phase 1 of the review of the Bachelor of Pharmacy programme, the Council for Higher Education (CHE) facilitated a workshop at a meeting held with heads of schools and representatives from skills development providers. Council took this opportunity to start the debate on work-based learning. A decision was made that a full-day workshop to discuss the best approach to work-based learning must be undertaken in 2019.
As part of the annual stakeholder engagement, the Practice Unit held a number of meetings with various groups, listed below:
• Health Science Academy (skills development provider) • Sefako Mokgatho University – PTDP (skills development provider) • Department of Correctional Services (pharmaceutical services,
Responsible Pharmacists (RPs) and management) • MediRite Group • Limpopo Provincial Pharmaceutical Services – (RPs and managers) • Mpumalanga Provincial Pharmaceutical Services – (RPs and
managers) • KwaZulu-Natal Provincial Pharmaceutical Services – (RPs and
managers) • eThekwini Metropolitan Municipality – (RPs and managers) • Netcare Group
Professional Affairs - Practice Mojo Mokoena (Senior Manager: Professional Affairs - Practice); Puseletso Mogano (Manager: Professional Affairs – Practice); Aziza Soopee (Manager: Professional Affairs – Practice); Nsovo
Mayimele (Manager: Professional Affairs – Practice); Nelisiwe Manyika (Secretarial Support Officer: Professional Affairs – Practice); Marie Koekemoer (Practitioner: Professional Affairs – Practice);
Humbulani Makamu (Officer: Professional Affairs – Practice); David Nkuna (Officer: Professional Affairs – Practice)
The activities of the Professional Affairs: CPD and Registrations Unit focus on four of Council’s strategic goals, which are to:
• uphold and safeguard the rights of the general public to universally acceptable standards of pharmacy practice in both the public and private sectors;
• establish, develop, maintain and control universally acceptable standards in pharmaceutical education and training;
• establish, develop, maintain and control universally acceptable standards for the registration of a person who provides one or more or all of the services, which form part of the scope of practice of the category in which such person is registered; and
• coordinate the activities of Council and its committees.
Committees
The CPD Committee and Health Committee meetings were held in March, June and August 2018.
Continuing Professional Development (CPD) Committee
In 2018, the CPD Committee chaired by Dr P Naidoo –
(a) evaluated 23 applications for candidates with qualifications obtained outside South Africa;
(b) developed criteria for interns who completed 365 days practical training but have not been successful in the pre- registration examination; and
(c) developed the blueprint for pre-registration examinations.
Health Committee
In 2018, the Health Committee chaired by Mr VC Dlamini managed 14 cases.
Registrations
The following categories of persons and organisations were registered during 2018. Most of these applications were submitted online, thus resulting in improved turnaround times and data integrity.
Category of persons and organisations Count*
Persons:
Community service pharmacists 674
Pharmacist’s assistant learners (basic and post-basic) 3 470
Pharmacy Technician (post-basic) 80
Pharmacy technician trainees 82
Tutors 1 592
Responsible Pharmacists 736
Recording of new licenses 353
Premises approval for training 786 Table 24: Number of persons and organisations registered in 2018 *Completed cases on the dashboard
First-year students’ information sessions were conducted at nine universities accredited by Council to offer the Bachelor of Pharmacy programme. During these sessions, students were informed about Council, the objectives of Council and the requirements for registration with Council. The first-year students’ registrations were facilitated and registrations cards were issued onsite.
The fourth-year students’ information sessions were conducted at nine universities accredited by Council, to provide the soon-to-be graduates with information on the requirements for pre-registration and pharmaceutical community service.
Meetings with the heads of pharmacy schools, skills development providers and heads of pharmaceutical services were held in 2018 to improve turnaround times and relationships between Council and the stakeholders.
Review of competency standards for pharmacists in South Africa
The competency standards for pharmacists in South Africa were approved by Council on 14/15 February 2018 and were published for implementation on 11 May 2018.
Pharmacy Internship
In 2018, the Intern and Tutor Manual which outlines all the pre- registration requirements was updated with the 2018 pre-registration evaluation schedules. The manual was published on the SAPC website
Professional Affairs – CPD and Registrations
Vusi Dlamini (Chairperson: Health Committee)
Dr Panjasaram (Vassie) Naidoo (Chairperson: CPD Committee)
together with the 2018 intern/tutor and pre-registration examination workshop presentations. Email and SMS notifications were sent to all interns, tutors and responsible pharmacists informing them of the availability of the manual and other information

Documents

Annual Report - SAPC